Study of Hyaluronic Acid Used With Gum Surgery to Treat Gum Recession in Adults

NCT07529340 | Not Yet Recruiting

• 1 other identifier: 24/2023
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Gingival recession is a common condition in which the gum tissue recedes, exposing the root surface of the tooth. This can lead to tooth sensitivity, higher risk of root decay, and aesthetic concerns. A commonly used surgical treatment is the coronally advanced flap combined with a connective tissue graft (CAF + SCTG), which aims to cover the exposed root and improve gum health. Hyaluronic acid (HA) is a naturally occurring substance in the body that plays an important role in wound healing. It may help improve tissue repair, reduce inflammation, and enhance healing after surgery. This study aims to evaluate whether the use of hyaluronic acid (hyaDENT BG®) in addition to standard surgical treatment improves clinical outcomes in patients with gingival recession. Participants will be randomly assigned to receive either standard treatment alone or standard treatment with hyaluronic acid. The main outcome is the proportion of sites with complete root coverage after 12 months. Additional outcomes include healing, gum tissue improvement, patient-reported pain and discomfort, and aesthetic results. The study also includes a laboratory component to investigate how hyaluronic acid affects cells involved in gum healing.

Conditions

Gingival Recession, Mucogingival Surgery

Keywords

Gingival recession; Coronally advanced flap; Connective tissue graft; Hyaluronic acid; Mucogingival surgery

Outcome Measures

Primary Outcomes (1)

• Complete Root Coverage (CRC)

  Proportion of treated sites achieving complete root coverage, defined as recession depth equal to 0 mm relative to the cemento-enamel junction, assessed using a calibrated periodontal probe by a blinded examiner.

  12 months

Secondary Outcomes (10)

• Mean Root Coverage (MRC)

  12 months

• Recession Reduction (RecRed)

  12 months

• Clinical Attachment Level (CAL) Gain

  12 months

• Probing Depth (PD) Reduction

  12 months

• Keratinized Tissue Width (KT) Gain

  12 months

Study Arms (2)

CAF + SCTG + Hyaluronic Acid

EXPERIMENTAL

Participants undergo coronally advanced flap (CAF) surgery combined with a subepithelial connective tissue graft (SCTG) with adjunctive application of cross-linked hyaluronic acid (hyaDENT BG®). The graft is immersed in hyaluronic acid prior to placement, and the gel is applied to the recipient site before flap closure.

Procedure: Coronally Advanced Flap with Connective Tissue Graft; Device: Cross-linked Hyaluronic Acid Gel

CAF + SCTG

ACTIVE COMPARATOR

Participants undergo coronally advanced flap (CAF) surgery combined with a subepithelial connective tissue graft (SCTG) without adjunctive hyaluronic acid. The graft is handled under standard conditions and hydrated with sterile saline prior to placement.

Procedure: Coronally Advanced Flap with Connective Tissue Graft

Interventions

Coronally Advanced Flap with Connective Tissue Graft PROCEDURE

Standard periodontal plastic surgery procedure for root coverage involving coronally advanced flap (CAF) combined with a subepithelial connective tissue graft (SCTG). The technique aims to cover exposed root surfaces and improve soft tissue thickness and stability.

Also known as: CAF + SCTG

CAF + SCTG; CAF + SCTG + Hyaluronic Acid

Cross-linked Hyaluronic Acid Gel DEVICE

Application of cross-linked hyaluronic acid gel (hyaDENT BG®) as an adjunct to periodontal surgery. The gel is applied to the recipient site and used to immerse the connective tissue graft prior to placement, aiming to enhance soft tissue healing, promote cell proliferation and angiogenesis, and improve clinical outcomes.

Also known as: hyaDENT BG®

CAF + SCTG + Hyaluronic Acid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Age ≥ 18 years, in good general health (ASA I or II)
• Presence of a single gingival recession defect classified as RT1 or RT2
• Recession depth ≥ 2 mm with identifiable cemento-enamel junction (CEJ)
• Presence of at least 1 mm of keratinized tissue at the defect site
• No active periodontal disease (probing depth ≤ 4 mm and no bleeding on probing at the selected tooth)
• Full-Mouth Plaque Score (FMPS ≤ 20%) and Full-Mouth Bleeding Score (FMBS ≤ 20%)
• Vital tooth without caries, cervical lesions, or defective restorations
• Good oral hygiene and motivation to maintain plaque control
• Ability and willingness to comply with study procedures
• Signed informed consent

You may not qualify if:

• Uncontrolled systemic diseases (e.g., uncontrolled diabetes, severe cardiovascular disease, immunodeficiency)
• Pregnant or breastfeeding women
• Autoimmune diseases or immunosuppressive therapy
• Known hypersensitivity to hyaluronic acid
• Heavy smokers (\>10 cigarettes/day) or recent tobacco use
• Active periodontal disease at the study site
• Caries, root fractures, endodontic lesions, or defective restorations at the study tooth
• Previous mucogingival surgery at the study site
• Recent use of antibiotics, corticosteroids, or anti-inflammatory drugs
• Coagulation disorders or anticoagulant therapy contraindicating surgery
• Hormonal disorders affecting wound healing
• Acute oral infections
• Any condition that may interfere with study participation or follow-up

Sponsors & Collaborators

• Universidade do Porto: lead
• Regedent AG, Zürich: collaborator

Study Sites (1)

CEPI - Clinical Center for Periodontology and Implantology

Porto, Porto District, 4350-110, Portugal

Location

Related Publications (3)

• Guldener K, Lanzrein C, Eliezer M, Katsaros C, Stahli A, Sculean A. Treatment of single mandibular recessions with the modified coronally advanced tunnel or laterally closed tunnel, hyaluronic acid, and subepithelial connective tissue graft: a report of 12 cases. Quintessence Int. 2020;51(6):456-463. doi: 10.3290/j.qi.a44492.

  PMID: 32368762 BACKGROUND

• Asparuhova MB, Kiryak D, Eliezer M, Mihov D, Sculean A. Activity of two hyaluronan preparations on primary human oral fibroblasts. J Periodontal Res. 2019 Feb;54(1):33-45. doi: 10.1111/jre.12602. Epub 2018 Sep 27.

  PMID: 30264516 BACKGROUND

• Pilloni A, Schmidlin PR, Sahrmann P, Sculean A, Rojas MA. Effectiveness of adjunctive hyaluronic acid application in coronally advanced flap in Miller class I single gingival recession sites: a randomized controlled clinical trial. Clin Oral Investig. 2019 Mar;23(3):1133-1141. doi: 10.1007/s00784-018-2537-4. Epub 2018 Jun 30. Erratum In: Clin Oral Investig. 2018 Nov;22(8):2961-2962. doi: 10.1007/s00784-018-2567-y.

  PMID: 29961138 BACKGROUND

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Central Study Contacts

Marta M Abreu-Costa

CONTACT

+351911834256; martacostaa11@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors responsible for clinical measurements and evaluation of study endpoints are blinded to treatment allocation to minimize assessment bias. Standardized measurement protocols and calibrated examiners are used to ensure consistency across all time points. The treating surgeon is not blinded due to the nature of the intervention, as the application of hyaluronic acid cannot be masked during the surgical procedure. Participants are not formally informed of their group allocation; however, complete blinding of participants cannot be guaranteed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 14, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-03

Locations

PT (1)